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Infusion IV of Mesenchymal Stem cellsWiki

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Correlated Drug Terms (1)

Name (Synonyms) Correlation
drug268 Azithromycin Capsule Wiki 1.00

Correlated MeSH Terms (3)

Name (Synonyms) Correlation
D055371 Acute Lung Injury NIH 0.10
D012127 Respiratory Distress Syndrome, Newborn NIH 0.10
D012128 Respiratory Distress Syndrome, Adult NIH 0.09

Correlated HPO Terms (0)

Name (Synonyms) Correlation

There is one clinical trial.

Clinical Trials

1 Mesenchymal Stem Cells for the Treatment of Severe Acute Respiratory Distress Syndrome Due to COVID-19. Pilot Study

Acute Respiratory Distress Syndrome (ARDS) is the main cause of death from COVID-19. One of the main mechanisms for ARDS is the violent storm of cytokines and chemokines, which cause uncontrolled fatal systemic inflammation by the immune system on the body, with additional multiple organ failure. Mortality in cases of severe ARDS caused by COVID 19 varies significantly between 50 and 90%, basically depending on the age of the patient and the presence of comorbidities. The plasticity of Mesenchymal Stem Cells (MSC) regulates inflammation and immunity. MSC can promote and inhibit an immune response, depending on the dynamics of inflammation and depending on the activation force of the immune system, the types of inflammatory cytokines present, and the effects of immunosuppressants. Essentially, the state of inflammation determines the immunoregulatory fate of MSC. Thus, IV application of AMSCa has been shown to control the inflammatory response in various diseases, such as the graft-versus-host reaction and the ARDS caused by H5NI. The objective of this study is to describe the clinical changes secondary to IV administration of MSC allogenic, in patients with bilateral COVID-19 pneumonia complicated by severe ARDS, with the evaluation of the PaO2 / FiO2 ratio, heart and respiratory rates, and the fever curve. Five patients, of either sex, over 18 years of age, with bilateral pneumonia caused by COVID-19 and severe SIRA that has not improved with the standard management measures used at that time in the care center, will be included in the study. This treatment will be administered after discussing it with the relatives that it is a procedure considered as rescue and will be carried out with informed consent. 1x10(6) xKg will be applied IV. The follow-up of the patient will be for three weeks. PaO2 / FiO2 data, fever, inflammatory markers and immunity will be evaluated. The results will be compared with the historical controls attended at INCMNSZ.

NCT04416139 Covid 19 Biological: Infusion IV of Mesenchymal Stem cells
MeSH:Respiratory Distress Syndrome, Newborn Respiratory Distress Syndrome, Adult Acute Lung Injury

Primary Outcomes

Description: To describe the clinical changes secondary to IV administration of AMSCa, in patients with bilateral COVID-19 pneumonia complicated by severe SIRA, with the evaluation of the PaO2 / FiO2 ratio.

Measure: Functional Respiratory changes: PaO2 / FiO2 ratio

Time: Three weeks

Description: To describe the clinical changes secondary to IV administration of AMSCa, in patients with bilateral COVID-19 pneumonia complicated by severe SIRA, with the evaluation of the heart rate per minute.

Measure: Clinical cardiac changes: Heart rate per minute

Time: Three weeks

Description: To describe the clinical changes secondary to IV administration of AMSCa, in patients with bilateral COVID-19 pneumonia complicated by severe SIRA, with the evaluation of the respiratory rate per minute.

Measure: Clinical Respiratory Changes: Respiratory rate per minute

Time: Three weeks

Description: To describe the clinical changes secondary to IV administration of AMSCa, in patients with bilateral COVID-19 pneumonia complicated by severe SIRA, with the evaluation of the fever curve in degrees centigrade.

Measure: Changes in body temperature

Time: Three weeks

Secondary Outcomes

Description: To assess the effect of the proposed treatment on the total Leukocytes

Measure: General biochemical changes in Leukocytes

Time: Three weeks

Description: To assess the effect of the proposed treatment on absolute lymphocytes

Measure: General biochemical changes on lymphocytes

Time: Three weeks

Description: To assess the effect of the proposed treatment on total platelets

Measure: General biochemical changes on platelets

Time: Three weeks

Description: To assess the effect of the proposed treatment on serum fibrinogen

Measure: General biochemical changes on fibrinogen

Time: Three weeks

Description: To assess the effect of the proposed treatment on procalcitonin

Measure: General biochemical changes on pocalcitonin

Time: Three weeks

Description: To assess the effect of the proposed treatment on ferritin

Measure: General biochemical changes on ferritin

Time: Three weeks

Description: To assess the effect of the proposed treatment on D-dimer

Measure: General biochemical changes on D-dimer

Time: Three weeks

Description: To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of C-reactive protein

Measure: Changes on inflammatory C-reactive protein

Time: Three weeks

Description: To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of TNFa in plasma.

Measure: Cahnges on Inflammatory cytokine TNFa

Time: Three weeks

Description: To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of IL10 in plasma.

Measure: Changes on Inflammatory cytokine IL10

Time: Three weeks

Description: To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of IL1 in plasma.

Measure: Changes on Inflammatory cytokine IL1

Time: Three weeks

Description: To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of IL6 in plasma.

Measure: Changes on Inflammatory cytokine IL6

Time: Three weeks

Description: To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of IL17 in plasma

Measure: Changes on Inflammatory cytokine IL 17

Time: Three weeks

Description: To assess the anti-inflammatory effect of the proposed treatment with assessment of the levels of VEGF in plasma

Measure: Changes on VEGF

Time: Three weeks

Description: Assess the radiological evolution of the proposed treatment through simple chest CT

Measure: Radiological Changes

Time: Three weeks

Description: Evaluate immune system improvement with mass cytometry to analyze patients' immune cells: regulatory T cells

Measure: Immunological changes on T cell

Time: Three weeks

Description: Evaluate immune system improvement with mass cytometry to analyze patients' immune cells: dendritic cells

Measure: Immunological changes on Dendritic cells

Time: Three weeks

Description: Evaluate immune system improvement with mass cytometry to analyze patients' immune cells: CD4 + T

Measure: Immunological changes on CD4+ T

Time: Three weeks

Description: Evaluate immune system improvement with mass cytometry to analyze patients' immune cells: CD8 + T

Measure: Immunological changes on CD8+ T

Time: Three weeks

Description: Evaluate immune system improvement with mass cytometry to analyze patients' immune cells: NK cells

Measure: Immunological changes on NK cell

Time: Three weeks

Description: Evaluate the safety of the proposed treatment (allergic reactions and / or infection)

Measure: Adverse events

Time: Three weeks

Description: To assess the negativization of the SARS-Cov2 PCR RNA detection test

Measure: RNA detection by SARS-Cov2 PCR

Time: Three weeks

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